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Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules - For the Public
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(PDF Version - 35 K)Contact: Marketed Health Products Directorate (MHPD)
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information should be discussed with your health professional.
This is duplicated text of a letter from Cobalt Pharmaceuticals Inc., Genpharm, Laboratoire Riva Inc., Novopharm Limited, Pharmascience Inc., ratiopharm, Sandoz Canada Inc. and Wyeth Canada.
Contact the appropriate company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on VENLAFAXINE XR
October 23, 2008
Subject: Safety Information Regarding Overdosage of Venlafaxine HCl Extended-Release Capsules
Health Canada, and the manufacturers of venlafaxine extended-release (XR) capsules wish to advise Canadians that the prescribing information for venlafaxine XR is being updated to include safety information about the risks of overdose.
Venlafaxine is in a class of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs), and is used to treat depression, generalized anxiety disorder (GAD), social anxiety disorder (or social phobia) and panic disorder. Venlafaxine XR is sold in Canada under several brand names, including Effexor XR, Co Venlafaxine XR, Gen-Venlafaxine XR, Riva-Venlafaxine XR, Novo Venlafaxine XR, PMS- Venlafaxine XR, Ratio-Venlafaxine XR, Sandoz Venlafaxine XR.
We are taking this opportunity to remind Canadians that:
- Patients experiencing depression are at increased risk of suicidal or self-harming thoughts or behaviours.
- Some patients taking antidepressants may feel worse instead of better, particularly within the first few weeks of treatment or when doses are adjusted. For example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts that could involve self-harm or harm to others.
- If you, or a family member or a friend are depressed or taking antidepressants, you should seek medical attention immediately if there are signs of worsening depression, especially thoughts or talk about self-harm or suicide.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of overdose or other serious or unexpected adverse reactions in patients receiving venlafaxine XR should be reported to the manufacturer or Health Canada at the following addresses:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario L5N 2B8
Telephone: 1-866-254-6111
Fax: 905-542-0478
Genpharm
Drug Safety
85 Advance Road
Etobicoke, Ontario M8Z 2S6
Telephone: 1-800-668-3174 ext. 152
Fax: 416-236-4363
E-mail: pharmacovigilance@genpharm.ca
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Quebec J7C 3V4
Telephone: 1-800-363-7988
Fax: 450-434-2500
Novopharm Limited
Pharmacovigilance and Drug Safety
30 Novopharm Court
Toronto, Ontario M1B 2K9
Telephone: 416-291-8888 ext. 5005
Fax: 416-335-4472
E-mail: PhV@Novopharm.com
Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montreal, Quebec H4P 2T4
Telephone: 1-800-363-8805
Fax: 514-342-7764
ratiopharm
17800 Lapointe
Mirabel, Quebec J7J 1P3
Telephone: 1-800-337-2584
Fax: 1-800-313-7673
Sandoz Canada Inc.
145, Jules-Leger
Boucherville, Quebec J4B 7K8
Telephone: 1-800-343-8839 ext. 4636
Fax: 1-888-243-6221
Wyeth Canada
Medical Information and Pharmacovigilance
50 Minthorn Boulevard
Markham, Ontario L3T 7Y2
Telephone: 1-800-461-8844
Fax: 905-470-4385
Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738
Authorized by:
Cobalt Pharmaceuticals Inc.
Genpharm
Laboratoire Riva Inc.
Novopharm Limited
Pharmascience Inc.
ratiopharm
Sandoz Canada Inc.
Wyeth Canada
